Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury.
1 other identifier
interventional
100
1 country
1
Brief Summary
There is evidence that has shown that serum testosterone levels are low in persons with chronic spinal cord injury (SCI). The question arises as to whether the defect in testosterone production is from the hypothalamic pituitary system (part of the brain that plays a role in testosterone release) or from the male testes. Studies to date are inconclusive. This study, will examine if persons with SCI has a normal hormonal regulation of the male hormone testosterone in comparison to persons who are able-bodied. This will help understand the physical and metabolic changes that occur in persons with SCI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedMarch 11, 2008
March 1, 2008
6.4 years
September 14, 2005
March 5, 2008
Conditions
Keywords
Study Arms (1)
1
OTHERInterventions
Eligibility Criteria
You may qualify if:
- SCI with serum total testosterone 3.0 ng/ml (SCI eugonadal, n=25),
- SCI with serum total testosterone \<3.0 ng/ml (SCI hypogonadal, n=25),
- able-bodied controls with serum total testosterone 3.0 ng/ml (control eugonadal, n=25), and
You may not qualify if:
- acute illness,
- active thyroid disease,
- pyschotropic medications,
- anti-hypertensive medications (centrally acting, i.e., guanethidine, reserpine, methyldopa, b-adrenergic blockers, clonidine, etc.),
- H2-blockers,
- digoxin,
- alcoholism,
- anti-convulsant medications (dilantin or barbiturates)
- diuretics (thiazides or spironolactone),
- chemotherapeutic agents,
- antibiotics,
- opiates,
- hormones (other than replacement doses),
- history of pituitary or testicular surgery. Abstinence from alcoholic beverages will be required for 48 hours prior to study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center, Bronx
The Bronx, New York, 10468, United States
Related Publications (2)
Tsitouras PD, Zhong YG, Spungen AM, Bauman WA. Serum testosterone and growth hormone/insulin-like growth factor-I in adults with spinal cord injury. Horm Metab Res. 1995 Jun;27(6):287-92. doi: 10.1055/s-2007-979961.
PMID: 7557841RESULTHuang TS, Wang YH, Chiang HS, Lien YN. Pituitary-testicular and pituitary-thyroid axes in spinal cord-injured males. Metabolism. 1993 Apr;42(4):516-21. doi: 10.1016/0026-0495(93)90112-2.
PMID: 8487676RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Bauman, MD
VA Medical Center, Bronx
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
July 1, 2001
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
March 11, 2008
Record last verified: 2008-03